Clinical Trial: Role of Leukotriene Receptor Antagonists in Treatment of Chronic Periodontitis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: The Effect Of SRP With Adjunctive Systemic Therapy Of Leukotriene Receptor Antagonist-Montelukast On The Serum C Reactive Protein Levels & Clinical Parameters In Chronic Peri

Brief Summary: The adjunctive use of Leukotriene Receptor Antagonist (Montelukast) along with scaling and root planing in patients with chronic periodontitis leads to host inflammatory response modulation and decrease in serum C reactive protein (CRP) levels. If proven this will open new vistas in treatment of chronic periodontitis.

Detailed Summary: A RCT was carried out to check the efficacy of Montelukast as an adjunct to scaling and root planing. The patients were randomised to either test group (SRP + Montelukast) and control group (SRP). Clinical parameters were assessed at baseline, 3 weeks and 6 weeks. Serum C-reactive protein levels were assessed at baseline, 3 weeks and 6 weeks.
Sponsor: Tatyasaheb Kore Dental College

Current Primary Outcome:

• Changes from baseline in the serum C- reactive protein levels at 3 weeks and 6 weeks [ Time Frame: baseline, 3 weeks and 6 weeks ]
  The biochemical parameter of serum C- reactive protein levels were checked at baseline, 3 weeks and 6 weeks. Montelukast therapy was started at baseline and continued for 3 weeks in test group and the post treatment levels were further checked at 6 weeks (i.e. 3 weeks after stoppage of Montelukast.) the change in C- reactive protein levels was analysed.
• Changes from baseline in the probing pocket depth at 3 weeks and 6 weeks [ Time Frame: baseline, 3 weeks and 6 weeks. ]
  The probing pocket depths were checked at baseline, 3 weeks and 6 weeks. Montelukast therapy was started at baseline and continued for 3 weeks in test group and the post treatment levels were further checked at 6 weeks (i.e. 3 weeks after stoppage of Montelukast.) The change in probing pocket depth was analysed.
• Changes from baseline in the clinical attachment level at 3 weeks and 6 weeks. [ Time Frame: baseline, 3 weeks and 6 weeks ]
  The clinical attachment levels were checked at baseline, 3 weeks and 6 weeks. Montelukast therapy was started at baseline and continued for 3 weeks in test group and the post treatment levels were further checked at 6 weeks (i.e. 3 weeks after stoppage of Montelukast.) The change in clinical attachment levels was analysed.

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Changes from baseline in Gingival Index (GI) at 3 weeks and 6 weeks [ Time Frame: baseline, 3 weeks and 6 weeks ]
  changes from baseline in standard clinical parameter, GI were assessed at 3 weeks after starting therapy with Montelukast, then therapy was stopped and same changes were again assessed at 6 weeks from baseline. GI has a scoring criteria specified by Silness & Loe, 1963.
• Changes from baseline in Plaque Index (PI) at 3 weeks and 6 weeks [ Time Frame: baseline, 3 weeks and 6 weeks ]
  changes from baseline in standard clinical parameter, PI were assessed at 3 weeks after starting therapy with Montelukast, then therapy was stopped and same changes were again assessed at 6 weeks from baseline. PI has a scoring criteria specified by Loe & Silness, 1964.
• Changes from baseline in Oral Hygiene Index-Simplified (OHI-S) at 3 weeks and 6 weeks [ Time Frame: baseline, 3 weeks and 6 weeks ]
  changes from baseline in standard clinical parameter, OHI-S were assessed at 3 weeks after starting therapy with Montelukast, then therapy was stopped and same changes were again assessed at 6 weeks from baseline. OHI-S has a scoring criteria specified by Greene and Vermilion, 1964.
• Changes from baseline in Sulcus Bleeding Index (SBI) at 3 weeks and 6 weeks [ Time Frame: baseline, 3 weeks and 6 weeks ]
  changes from baseline in standard clinical parameter, SBI were assessed at 3 weeks after starting therapy with Montelukast, then therapy was stopped and same changes were again assessed at 6 weeks from baseline. SBI has a scoring criteria specified by Muhleman (1971).

Original Secondary Outcome: Same as current

Information By: Tatyasaheb Kore Dental College

Dates:
Date Received: December 12, 2013
Date Started: March 2012
Date Completion:
Last Updated: December 18, 2013
Last Verified: December 2013